Identity
- Trade Name
- Aquaplast RT™ FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Aquaplast PR 5-Point, 2.4mm Locks FDA UDI
- Model / Reference
- RT-1778PR5D FDA UDI
- Description
- Aquaplast PR 5-Point, 2.4mm Locks FDA UDI
Identifiers
- Catalog Number
- RT-1778PR5D FDA UDI
- Primary DI / UDI-DI
- 10841962103111 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Depth — 2.4 Millimeter FDA UDI
Aquaplast RT™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (1)
- FDA UDI d00ee450-5383-4a89-b98a-7b48c892f520 37 fields · synced Jun 1, 2026